Randomized Study of Sequential Orbital Radiotherapy for Graves' Ophthalmopathy

Not Applicable

Completed

• Conditions: Graves' Disease

• Registration Number: NCT00004660
• Lead Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Brief Summary

OBJECTIVES: I. Evaluate the effects of 20 Gy of external-beam radiotherapy to 1 orbit vs. the untreated orbit at 3 and 6 months after therapy in patients with Graves' ophthalmopathy.

II. Evaluate whether 20 Gy of external-beam radiotherapy delivered to the second orbit 6 months later in the course of the disease produces effects of equal magnitude to those observed when the first orbit was treated.

III. Relate the magnitude of treatment effects to the time since onset of eye symptoms.

IV. Evaluate whether characteristics of radiation retinopathy are present 3 years after orbital radiotherapy.

Detailed Description

PROTOCOL OUTLINE: The posterior region of 1 orbit is irradiated over 2 weeks with supervoltage equipment. The other orbit is treated 6 months later. The sequence of therapy is randomly assigned.

The untreated eye receives a simultaneous sham treatment during each radiotherapy session.

Patients are followed at 3, 6, 9, 12, and 36 months.

Study Timeline

• Study Start: 1993-06
• Primary Completion: 1998-01
• Study Completion: 1998-01
• Study First Submitted: 2000-02-24
• Study First Submitted QC: 2000-02-24
• Study First Posted: 2000-02-25
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-25
• Last Update Posted: 2017-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Orbital Volume	1 year	Orbital fat and muscle volumes

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States